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Accessing Quality Assured Supplies (AQAS) An MDAWG Initiative

Accessing Quality Assured Supplies (AQAS) An MDAWG Initiative. Addis Ababa, June 2011. Project summary. The AQAS Initiative was undertaken - December 2009-February 2011 through a grant from the RHSC Innovation Fund The project goal;

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Accessing Quality Assured Supplies (AQAS) An MDAWG Initiative

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  1. Accessing Quality Assured Supplies (AQAS)An MDAWG Initiative Addis Ababa, June 2011 Lester Chinery

  2. Project summary • The AQAS Initiative was undertaken - December 2009-February 2011 through a grant from the RHSC Innovation Fund The project goal; • To identify a group of hormonal contraceptive manufacturers with the capacity and intention to apply for prequalification of products by WHO within two years, and are willing to provide low-cost, products of assured quality to less developed country markets. • 27 companies surveyed

  3. Objectives • To assess the current status and capability of selected hormonal contraceptive manufacturers to achieve prequalification of products by WHO and provide products of assured quality for public and social marketing programmes in less developed countries • Outcome-a group of 25-30 companies exists whom, with support, have the potential to achieve PQ for 1 or more of their products over 1-5 to years. The timeframe for each will depend upon - level of support, investments required, speed of action and perceived value of WHO PQ. Of these, there are 10-12 who should be able to comply with WHO requirements within a shorter timeframe of 1-3 years

  4. Company segmentation

  5. Cat D – not capable

  6. Objectives • To identify the outstanding process and manufacturing challenges/deficits of each company in relation to CGMP, the additional requirements for bioequivalence, and the provenance/suitability of Active Pharmaceutical Ingredients used. To document the cost and time of remedial/additional actions required • Outcome-the project provided in-depth technical support to 12 companies, including on-site assessments and assistance to 6. The current status of these companies is known; the action required identified and costed and forward action plans in place. All of this information has been documented and provided to the individual manufacturers

  7. AQAS – technical challenges

  8. Objectives • To raise awareness of WHO-PQP among companies, the benefits of participation, through the development of a guide for manufacturers in collaboration with WHO. To inform members of the RHSC of the current challenges in ensuring a continual supply of quality assured products for country programmes • Outcome-31 manufacturers were provided with information on the WHO programme and its requirements, 13 received the Frequently Asked Questions document and updates to guidelines and new WHO Technical Report Series alerts • 25 copies of the FAQ were distributed at the WHO Prequalification Stakeholders and Manufacturers meeting • FAQ document available on PQP website

  9. Objectives (3 continued) • Direct face to face discussions about the programme was provided to senior managers/owners and technical staff of 11 companies • RHSC publication – Medicines for RH, Ensuring Access to Quality Assured Products was developed

  10. Objectives (3 continued) • RHSC-MDA Working Group meeting - November 2009, Washington DC. • RHSC-SS Working Group meeting - December 2009, Copenhagen. • RHSC-MDA Working Group meeting - May 2010, Kampala. • RHSC – Annual Meeting (as part of the Quality Medicines for RH session) - May 2010, Kampala. • International Consortium for Emergency Contraception (ICEC) Annual Meeting - Sept 2010, New York • RHSC-MDA Working Group meeting - November 2010, Washington DC • UNFPA- PSB staff briefing - January 2011, Copenhagen • Various briefing meetings with WHO, BMGF and UK DFID-2010/11

  11. Main findings • A group of 25-30 companies exists whom, with support, have the potential to achieve PQ for 1 or more of their products over 1-5 to years. Of these, there are 10-12 who should be able to comply with WHO requirements within a shorter timeframe of 1-3 years • Some potential “good” candidates have minimal interest in PQ and serving less developed markets • Incentivizing manufacturers is a key issue – assisting with understanding market dynamics & achieving an equitable purchasing platform for those who invest • Increased harmonization of QA approaches – at international and national levels – incentivize the willing • Better communication, clarity and linkages between PQP and those willing to engage/are engaged. • Registration at the country level is, and will remain a critical factor

  12. Conclusions • It is feasible to establish a competitive roster of companies providing quality assured products over next 2-3 years. These products could offer a 30-50 price advantage over existing QA offerings • A critical mass of companies are currently/ prepared to raise standards • There is a significant issue re incentivizing manufacturers • Some companies do not feel under pressure from customers to increase standards • More clarity is required on the PS market-pace, conditions, scope and segmentation for business planning and decision-making • Communication/information gap between PQP and industry • Bringing new manufacturers through would ideally be a coordinated multi-agency interim strategy

  13. Thank - you Lester Chinery

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